1. Field
The present invention relates to an apparatus and a method for achieving rapid hemostasis in sealing a puncture in a tubular tissue structure or the wall of a body cavity. More particularly, the present invention is directed to sealing a puncture site with submucosal tissue or another extracellular matrix-derived tissue capable of remodeling endogenous connective tissue.
2. Description of Related Art
The control of bleeding during and after surgery is important to the success of the procedure. The control of blood loss is of particular concern if the surgical procedure is performed directly upon or involves the patient's arteries and veins. Well over one million surgical procedures are performed annually which involve the insertion and removal of catheters into and from arteries and veins. Accordingly, these types of vasculature procedures represent a significant amount of surgery in which the control of bleeding is of particular concern.
Typically, the insertion of a catheter creates a puncture through the vessel wall and upon removal the catheter leaves a puncture opening through which blood may escape and leak into the surrounding tissues. Therefore, unless the puncture site is closed clinical complications may result leading to increased hospital stays with the associated costs. To address this concern, medical personnel are required to provide constant and continuing care to a patient who has undergone a procedure involving an arterial or venous puncture to insure that post-operative bleeding is controlled.
Surgical bleeding concerns can be exacerbated by the administration of a blood thinning agent, such as heparin, to the patient prior to a catheterization procedure. Since the control of bleeding in anti-coagulated patients is much more difficult to control, stemming blood flow in these patients can be troublesome. A common method of healing the puncture to the vessel is to maintain external pressure over the vessel until the puncture seals by natural clot formation processes. This method of puncture closure typically takes about thirty to ninety minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated.
Furthermore, it should be appreciated that utilizing pressure, such as human hand pressure, to control bleeding suffers from several drawbacks regardless of whether the patient is hypertensive or anti-coagulated. In particular, when human hand pressure is utilized, it can be uncomfortable for the patient, can result in excessive restriction or interruption of blood flow, and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags, or clamps require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure the effectiveness of these techniques.
Other devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture. In current practice, submucosal tissue or another extracellular matrix-derived tissue is used to seal punctures in tubular tissue structures, such as blood vessels, or in the wall of a body cavity. The prior art method of placing the submucosal or extracellular matrix-derived tissue is described in U.S. Pat. No. 6,790,220, which is herein incorporated by reference, a simplified version of which is reproduced in FIGS. 1A-1D.
An introducer 10 with a sheath 11 carrying a ribbon or sheet 12 of extracellular matrix-derived tissue is inserted through the skin, the underlying muscle tissue, and through the blood vessel wall. Ribbon or sheet 12 includes a cuff 14 and an extended length 15. The cuff 14 is usually situated and secured directly above a hole 13 in the sheath 11, in which the extended length 15 is inserted. The outer diameter of the cuff 14 is greater than the outer diameter of the sheath 11. As is also shown in FIG. 1A, pull-up tether 16 is woven through the extended length 15 and pull down tether 18 is woven into the cuff 14 and both tethers are exposed externally. The introducer 10 is inserted until the greater diameter of the cuff 14 prevents further insertion of the introducer 10. The cuff 14 is then released so that it is free to move relative to the sheath 11. The sheath 11, is advanced as the cuff remains in position and the extended length is withdrawn from the interior of the sheath 11 through the hole 13.
When the procedure is completed, the entry to the artery will need to be closed. As shown in FIGS. 1B-1D, the user pulls the tethers 16, 18 to bunch the ribbon or sheet 12 into a ball 15. When the sheath remains inserted, the ball 15 is held to the side of the puncture site by the sheath 11. When the sheath is removed, the ball 15 moves into the puncture site, sealing the puncture site immediately. When the user determines that the patch completely seals the hole in the tubular structure, the tethers 16, 18 may then be cut and removed.
This method of sealing a hole in a tubular structure has an excellent safety profile, but can suffer from inconsistent tether compression of the device. If the user pulls too hard on the tether, the ribbon or sheet may be pulled out of position to seal the hole. At the same time, if the user does not pull hard enough on the tether, the ribbon or sheet will not be compressed sufficiently to effectively seal the hole. Even after the ribbon or sheet is compressed into a ball, by removing the sheath a space is created within the cuff. An incomplete mechanical closure of the hole may contribute to longer hold times being necessary to reach hemostasis. Some users advocate adding a “little” pull on the suture tether to further tighten the ball after removing the sheath, but it's success is very operator dependent and inconsistent.
In addition, in order to determine when hemostasis has been achieved, the user must hold pressure externally on the skin over the puncture site and intermittently check for bleeding at the skin level. However, this method is not consistent in revealing what is actually going on at the arteriotomy site, sometimes very deep inside other tissue. This uncertainty can lead to hold times that are longer or shorter than needed contributing to hematomas or ecchymosis.
Accordingly, there is a need for surgical techniques suitable for sealing punctures in a tubular tissue structure or in the punctured wall of a body cavity, such as a heart chamber, or a body cavity of another organ, that is more consistent between users and allows more certainty in determining hemostasis.